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Compliance ★ India, 2015-02-18 05:30 (3353 d 17:30 ago) Posting: # 14451 Views: 3,725 |
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Dear Member, I need your expert advice in following: "what would be the agency's look out if single ANDA contains two different method for subject sample analysis at two different site (any of the study condition i.e. fast or fed on different method). Method contains same range but having difference in the extraction process (i.e. SPE Vs. LLE)and mobile phase composition". please share your expert thoughts on this and help me in such situation. Regards, Compliance |
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janmacek ☆ Czech Republic, 2015-02-18 10:06 (3353 d 12:54 ago) @ Compliance Posting: # 14453 Views: 2,990 |
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Dear Compliance, do I understand it correctly that you have two studies, one fasting and one fed, and in each study a different method was used? In this case I would not expect any problems if the analytical methods are both validated according to the respective guidelines. With kind regards, Jan |
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Compliance ★ India, 2015-02-18 12:16 (3353 d 10:44 ago) @ janmacek Posting: # 14455 Views: 3,009 |
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❝ do I understand it correctly that you have two studies, one fasting and one fed, and in each study a different method was used? Yes you are right & also note that both of the method are going to be fully validated as per the guideline. thanks for sharing your opinion. Regards, Compliance |
Ing. Helmut Schütz